Prescription drug · ANDA
Finasteride NDC 68788-8275
Finasteride 1 mg/1 · Tablet, Coated · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8275-3 | 6878882750368788827503 | 30 TABLET, COATED in 1 BOTTLE (68788-8275-3)Marketed from Oct 14, 2022 | |
| 68788-8275-6 | 6878882750668788827506 | 60 TABLET, COATED in 1 BOTTLE (68788-8275-6)Marketed from Oct 14, 2022 | |
| 68788-8275-9 | 6878882750968788827509 | 90 TABLET, COATED in 1 BOTTLE (68788-8275-9)Marketed from Oct 14, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Finasteride
- Generic name (nonproprietary)
- finasteride
- Active ingredients
- Finasteride — 1 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207750
- Marketing start
- Listing expires
- Other FDA classes
- 5-alpha Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 68788-8275_a4242cc3-63e0-4514-8594-e69887285baaSPL ID a4242cc3-63e0-4514-8594-e69887285baaSPL set ID b84a67d6-695e-4a7c-9b60-95e9ad18a501RxCUI 200172UNII 57GNO57U7G
- Pharmacologic class
- 5-alpha Reductase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468788827503followed by a unit qualifier and the quantityPackage 68788-8275-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Finasteride tablets is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY . Efficacy in bitemporal recession has not been established. Finasteride tablets is not indicated for use in women. • Finasteride tablets is a 5α-reductase inhibitor indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY ( 1 ). • Finasteride tablets is not indicated for use in women ( 1 , 4 , 5.1 ).
Excerpt only. Read the full label for complete information.
About NDC 68788-8275
- What is NDC 68788-8275?
- 68788-8275 is the product NDC for Finasteride, Finasteride 1 mg/1 tablet, coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Finasteride.
- What is the active ingredient?
- Finasteride.
- Who is the labeler?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Finasteride?
- 68 other product NDCs are listed under this name. See all Finasteride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Finasteride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Finasteride | Finasteride 1 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4687 | 70518-4687-00 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1058 | 67046-1058-03 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2639 | 55154-2639-00 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8749 | 68788-8749-0168788-8749-0368788-8749-06+1 more |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8433 | 68788-8433-0168788-8433-0368788-8433-06+1 more |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-542 | 72189-0542-3072189-0542-90 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-8377 | 68788-8377-0168788-8377-0368788-8377-06+1 more |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3616 | 70518-3616-0170518-3616-0370518-3616-04+1 more |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3600 | 70518-3600-0170518-3600-0370518-3600-04 |
| Finasteride | Finasteride 1 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-714 | 47335-0714-0847335-0714-1847335-0714-81+2 more |
Other NDCs under ANDA 207750
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Finasteride | Finasteride 1 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-4648 |
| Finasteride | Finasteride 1 mg/1 | Tablet, CoatedOral | Ascend Laboratories, LLC | 67877-455 |
| Finasteride | Finasteride 1 mg/1 | Tablet, CoatedOral | NuCare Pharmaceuticals, Inc. | 68071-3744 |
| Finasteride | Finasteride 1 mg/1 | Tablet, CoatedOral | REMEDYREPACK INC. | 70518-2287 |
| Finasteride | Finasteride 1 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 71205-790 |
| Finasteride | Finasteride 1 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-1304 |
| Finasteride | Finasteride 1 mg/1 | TabletOral | Thirty Madison Inc | 71713-099 |